Senior Scientist I, Method Development (Immunoassay)

Pharmaron; Germantown (MD); Presencial; USD 95 000 - 115 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, Dental & Vision Insurance

401(k) Retirement Plan

Paid Time Off

Resumo da oferta

Pharmaron in Germantown, MD, is seeking a Senior Scientist I in Immunoassay method development. This hands-on role requires leading projects from design through completion, troubleshooting, and providing scientific guidance to junior scientists in a regulated CRO bioanalytical lab.

You will develop large-molecule ligand-binding assays for PK, ADA, and biomarker programs, with platforms including MSD, Gyros, and ELISA, while collaborating with sponsors and internal teams to ensure timely delivery.

Qualificações

• PhD in a relevant scientific discipline with 5–6 years of experience in regulated large-molecule bioanalytical environments, including 3–4 years of independent method development leadership.
• Strong hands-on experience across PK, ADA, and biomarkers.
• Previous CRO or client-facing bioanalytical experience.
• Independent method development leadership.
• Experience with multiple LBA platforms and deep troubleshooting experience.

Responsabilidades

• Independently lead day-to-day method development activities for assigned programs.
• Design, execute, analyze, and document experiments following SOPs and regulatory expectations.
• Own projects from initial method optimization through pre-validation, and validation or qualification when applicable.
• Troubleshoot and resolve unexpected assay results with data-driven decisions.
• Communicate results and recommendations to sponsors and internal stakeholders; mentor junior staff.

Conhecimentos

Method development

Biomarker assays

PK/ADA

Troubleshooting

Team mentorship

Regulated CRO lab

Formação académica

PhD

Master's degree

Bachelor's degree

Ferramentas

MSD

Gyros

AlphaLISA

ELISA

SoftMax

Watson LIMS

Descrição da oferta de emprego

Position: Senior Scientist I, Method Development (Immunoassay)

Salary: $95K-$115K

Location: Germantown, MD

About Pharmaron

Pharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 28 locations in the US, UK, China, and Singapore, we support drug discovery through to manufacturing with fully integrated high-quality services. We’re proud of the impact we make and just last year, we supported 887 discovery projects, 1,100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,300 global customers. To learn more, visit www.pharmaron.com.

About The Role

We are seeking an independent, hands-on Senior Scientist I with strong large-molecule bioanalytical method development experience to join our Immunoassay team in Germantown, MD. This role is ideal for a scientist who can own method development projects from experimental design through completion, work through technical challenges independently, and apply sound scientific judgment when assays do not perform as expected. The successful candidate will bring experience working in a regulated CRO bioanalytical laboratory environment, with broad hands-on expertise across PK, ADA, and biomarker assays. This person should be comfortable working at the bench, troubleshooting complex assay issues, communicating directly with sponsors and internal stakeholders, and providing technical guidance to junior scientists. This is a hands-on scientific role, not simply a project oversight position. We are looking for someone who can independently assess a problem, determine the appropriate experimental path forward, execute the work, interpret the data, and see the project through to a successful outcome.

What You'll Do

Own Method Development Projects

• Independently lead day-to-day method development activities for assigned preclinical and clinical programs.
• Design, execute, analyze, and document experiments in accordance with SOPs, regulatory expectations, and project requirements.
• Take ownership of projects from initial method optimization through pre-validation and, when applicable, validation or qualification.
• Aid in identifying technical issues in Method Qualification/Validation or Sample Analysis and determine appropriate troubleshooting strategies.
• Work through unexpected experimental results and see technical challenges through resolution and project completion.
• Ensure methods are scientifically sound, robust, reproducible, and fit for their intended purpose and stage of drug development.

Apply Broad Bioanalytical Expertise

• Develop and optimize large-molecule ligand-binding assays (LBA) supporting:
• Pharmacokinetics (PK)
• Anti-drug antibodies (ADA)
• Biomarkers/PD
• Apply expertise across a range of large-molecule modalities, including monoclonal antibodies, bispecifics, ADCs, ASOs, fusion proteins and peptides.
• Use sound scientific judgment to select and optimize assay formats, reagents, platforms, and experimental conditions.
• Interpret assay performance and make data-driven decisions regarding method refinement.

Troubleshoot & Solve Problems

We are looking for a scientist who does more than execute established procedures. You should be able to:

• Recognize when an assay is not performing as expected.
• Develop a logical troubleshooting strategy.
• Design experiments to identify root causes.
• Evaluate competing hypotheses and determine the most scientifically appropriate path forward.
• Optimize assay conditions based on experimental data.
• Make independent decisions while knowing when escalation or additional input is appropriate.
• Drive problems through resolution rather than simply identifying them.

Work Directly with Sponsors & Internal Teams

• Serve as a technical point of contact for assigned studies.
• Participate in sponsor discussions and provide clear, scientifically sound study updates.
• Present and explain experimental results, conclusions, challenges, and recommendations.
• Collaborate with project teams, laboratory staff, leadership, and Business Development.
• Support proposal development, study scoping, and technical discussions when needed.
• Manage multiple priorities while maintaining quality and project timelines.

Mentor & Provide Scientific Leadership

• Provide technical guidance and day-to-day scientific support to junior laboratory staff.
• Review experimental approaches, data, and documentation.
• Help establish strong scientific and laboratory practices across the team.
• Contribute to scientific presentations, conferences, posters, and publications when appropriate.

Required Experience

• PhD in a relevant scientific discipline with 5–6 years of experience in regulated large-molecule bioanalytical environments, including 3–4 years of independent method development leadership; or
• Master's degree with 6–7 years of relevant experience, including 4–5 years of independent method development leadership; or
• Bachelor's degree with 7–8 years of relevant experience, including at least 5–6 years in a regulated environment supporting large-molecule drug development.

Critical Qualifications/The strongest candidates will have:

• Previous CRO or client-facing bioanalytical experience
• Demonstrated ability to independently own method development projects from design through completion
• Strong hands‑on experience across PK, ADA, and biomarkers
• Deep troubleshooting and assay optimization experience
• Hands‑on experience with multiple LBA platforms
• Ability to communicate directly with sponsors and defend scientific decisions
• Experience working through complex technical problems without requiring extensive direction

Bioanalytical Platforms

• MSD
• Gyros
• AlphaLISA / Alpha
• ELISA Spectrophotometry
• Similar established ligand-binding assay platforms

Experience with flow cytometry and/or PCR-based platforms is an added plus.

What Success Looks Like

Experience with SoftMax and Watson LIMS is strongly preferred.

Success in this role means you can take a method development problem and own it.

You will be expected to:

• Develop methods on time and ensure they meet scientific and project requirements.
• Responsible for monthly Method Development financial revenue targets.
• Work independently while appropriately escalating critical issues.
• Identify assay problems quickly and develop effective troubleshooting strategies.
• Make scientifically defensible decisions based on data.
• Drive experiments through optimization and resolution rather than stopping at problem identification.
• Deliver complete, well-documented, high-quality work.
• Clearly communicate results, challenges, and recommendations to sponsors and internal stakeholders.
• Provide meaningful scientific guidance to junior staff.
• Build strong client relationships through reliable execution and technical expertise.

Why Pharmaron?

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 25,000 employees and operations in the US, UK, China, and Singapore. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.

Benefits

• Comprehensive Medical, Dental & Vision Insurance with significant employer contributions
• 401(k) Retirement Plan with generous employer matching
• Generous Paid Time Off (PTO), Paid Sick Leave & Company Holidays to support work-life balance
• Employer-funded Health Savings Account (HSA) contributions (for eligible plans), plus Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer-paid Employee Life Insurance, AD&D, Short- and Long-Term Disability Insurance
• Employee Assistance Program (EAP), mental health resources,